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Bhasker Sambar

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Reminder for the upcoming Webinar - Digital Twins (Regulatory Science Community meeting)

Posted By Bhasker Sambar 06-25-2026 12:45
Found In Egroup: RegulatoryScience Community \ view thread
Hello community members, A quick reminder about tomorrow's topic for discussion - Digital Twins. This is a great opportunity to learn what a virtual replica is and how digital twins are being applied in biopharmaceutical and pharmaceutical Industry. If you haven't registered yet, please use the link ...

Reminder for the upcoming Webinar - Digital Twins (Regulatory Science Community meeting)

Posted By Bhasker Sambar 06-25-2026 12:45
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
Hello community members, A quick reminder about tomorrow's webinar on Digital Twins. This is a great opportunity to learn what a virtual replica is and how digital twins are being applied in biopharmaceutical and pharmaceutical Industry. If you haven't registered yet, please use the link below to ...

RE: June 26 from noon to 1pm A digital twins conversation with Dough Kiehl and monthly Regulatory Science meetings

Posted By Bhasker Sambar 06-22-2026 22:37
Found In Egroup: RegulatoryScience Community \ view thread
Thank you, Allison. This is a great update, and moving our meetings to AAPS Science 360 will make it much easier for members to register, track sessions, and stay engaged. This month's digital twins discussion with Douglas Kiehl is an excellent opportunity for anyone interested in modeling, quality, ...

FDA FY 2026 Generic Drug Science & Research Workshop - Topics for Submission

Posted By Bhasker Sambar 06-15-2026 10:13
Found In Egroup: Pharmaceutical Quality Community \ view thread
Hi all, FDA held its annual GDUFA Generic Drug Science and Research Initiatives Public Workshop on June 8–9, 2026 (White Oak, hybrid). Beyond the workshop itself, FDA has an open public docket inviting topic ideas for the FY 2027 GDUFA Science and Research Priorities - and I'd like us to pull together ...

FDA FY 2026 Generic Drug Science & Research Workshop - Topics for Submission

Posted By Bhasker Sambar 06-15-2026 10:12
Found In Egroup: RegulatoryScience Community \ view thread
Hi all, FDA held its annual GDUFA Generic Drug Science and Research Initiatives Public Workshop on June 8–9, 2026 (White Oak, hybrid). Beyond the workshop itself, FDA has an open public docket inviting topic ideas for the FY 2027 GDUFA Science and Research Priorities - and I'd like us to pull together ...

RE: May 22 from noon to 12:30 pm ET - 30 Minutes, One Question: Where Should Regulatory Science Focus?

Posted By Bhasker Sambar 05-21-2026 17:52
Found In Egroup: RegulatoryScience Community \ view thread
Hi Allison, A few focused areas where I believe Regulatory Science can make a meaningful impact: Establishing clear, risk‑based expectations for AI and Digital Twin credibility, validation, and lifecycle management, especially as these models begin influencing CMC and GMP decision‑making. ...

AI and Digital Twins in Pharmaceutical manufacturing

Dear MSE Community Members, With the growing interest in AI and Digital Twin technologies across CMC and pharmaceutical manufacturing, I'm interested in learning how different organizations are implementing these models and preparing them for regulatory review. Many of us are navigating similar questions ...

RE: Call for Volunteers – Scientific Team: Specifications of Pharmaceutical Products

Posted By Bhasker Sambar 05-21-2026 13:59
Found In Egroup: Pharmaceutical Quality Community \ view thread
Dear Kim and PQC Leadership Team, I hope you are doing well. I am very much interersted for this volunteer oppertunity. With over 15 years of experience in pharmaceutical development-spanning sterile injectables, drug–device combination products, CMC strategy, analytical method development, and regulatory ...

RE: Call for Volunteers – Scientific Team: AI/ML in Product Quality

Posted By Bhasker Sambar 05-17-2026 18:02
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
Hi Kim, Can you pls provide an update about this opportunity. Appreciate your response. Thanks! ------------------------------ Bhasker Sambar Sr. Manager, External R&D and Technical Services Alvogen INC Exton PA [email protected] Disclaimer: Opinions expressed are solely my own and do not express ...

RE: Call for Volunteers – Scientific Team: AI/ML in Product Quality

Posted By Bhasker Sambar 05-12-2026 09:22
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
Hi, I am interested in this volunteer position. please provide more details. This is Bhasker Sambar, pharmaceutical professional with 15 years of experience in R&D and technical services Thanks ------------------------------ Bhasker Sambar Sr. Manager, External R&D and Technical Services ...